FIELD OF THE INVENTION
The present invention relates to methods for treating the hyperplasia caused by a papilloma virus, such as Condyloma epithelial cells of mammals and which causes uncontrolled cell replication. There are many types of papilloma virus which infect human and animal species, but they all can infect the basal epithelial cells and persist in an episome or as DNA integrated into the host genome. The mechanism by which they cause tissue growth may be related to the E4 and E5 proteins they all produce in related forms, which appear to interact with p54 and other host proteins which control the cell cycle. The effects of papilloma virus which have been described include genital warts or Condylomata acuminate, common warts, plantar warts, bovine papillomas, and cervical intra-epithelial neoplasia in women.
The detection of human papilloma virus ("HPV") in Condyloma acuminata involve a method of taking a tissue sample or a smear from the infected area and determining the DNA of the virus. According to this method, the detection rate is almost 100%.
Types HPV6 and 11 of the virus are the ones most commonly detected and because HPV16 has been detected in malignant squamous cell carcinoma from cancer of the penis, cancer of the cervix and Condyloma acuminata, there is a strong possibility that HPV16 is related to the malignancy of Condyloma acuminata.
Means for the treatment of Condyloma acuminata caused by human papilloma virus which have been tried include physical means such as surgical excision, electrocauterization, cryosurgery, laser therapy, etc., and medications such as applications of Podophyllin, 5-Fluorouracil, Bleomycin, Interferon, Imiquimod, etc., which are presently available. However, surgical treatment is distressing for the patient, considering the site of infection, and with topical applications there is the concern of side-effects. The aforesaid medications work either by cytotoxic tissue destruction or by enhancing the cellular immune response by causing local inflammation. Accordingly, a conclusive treatment has heretofore not been available.
Condyloma acuminata has a high rate of recurrence, and a complete cure is difficult unless treated constantly. Therefore, a treatment which has a high degree of safety and is convenient is strongly desired.
A treatment regimen for hyperplasia caused by a papilloma virus, such as Condyloma acuminata, which would be easy for the patient to administer, is desired. For example, it would desirable to have a medication which can be taken orally and can be applied to the affected area by the patients themselves and which would provide good results after a relatively short period of use and have no side-effects.